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FDA 510(k)

PLANMECA INTRACAM STATION

K-Number: K984013 · 1999-01-26

ApplicantPlanmeca Oy
Decision Date1999-01-26
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLANMECA INTRACAM STATION is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 1999-01-26 under 510(k) number K984013. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLANMECA INTRACAM STATION?

PLANMECA INTRACAM STATION is a medical device that received FDA 510(k) clearance on 1999-01-26. The listed applicant is Planmeca Oy. The 510(k) number is K984013.

When did PLANMECA INTRACAM STATION receive FDA 510(k) clearance?

PLANMECA INTRACAM STATION received FDA 510(k) clearance on 1999-01-26, under 510(k) number K984013.

Who is the listed applicant for PLANMECA INTRACAM STATION?

The FDA 510(k) record lists Planmeca Oy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLANMECA INTRACAM STATION?

The FDA product code for PLANMECA INTRACAM STATION is EIA.

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Other records listing Planmeca Oy as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230985Planmeca VisoK200572Planmeca RomexisK181576Planmeca VisoK171385Planmeca RomexisK160506Planmeca ProMax 3D Max, Planmeca MaximityK103689PLANMECA PROMAX 3D MID

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Related Devices (Code: EIA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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